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The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.

Several agents are being investigated for the treatment of patients with glioblastoma in an ongoing phase II clinical trial. Known as the INdividualized Screening Trial of Innovative Glioblastoma Therapy, the study will randomize patients to 1 of 4 arms—either the control arm of standard-of-care agent temozolomide, or 1 of 3 experimental arms.

The novel oncolytic virus Toca 511 (vocimagene amiretrorepvec) and Toca FC (extended-release 5-fluorocytosine [5-FC]) induced durable responses in patients with recurrent glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), for a median duration of response of 35.1+ months, according to findings from a phase I study presented during the 2017 AACRNCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In a pooled analysis of 3 phase I studies, the virus also proved to be well tolerated with fewer any-grade adverse events (AEs) than with standard chemotherapy.1

Disease-free survival  is maintained in women with postmenopausal hormone receptor-positive breast cancer treated with aromatase inhibitors, even when the treatment is only given for 2 years in comparison with the standard 5 years of additional aromatase inhibitor therapy, according to findings from the phase III ABCSG-16 trial presented at the 2017 San Antonio Breast Cancer Symposium. 

After previously receiving an accelerated approval, bevacizumab (Avastin) has been granted a full approval by the FDA for the treatment of adult patients with glioblastoma that progressed following prior therapy, according to Genentech, the manufacturer of the VEGF inhibitor.